免除伦理审查制度适法性与可操作性探讨

结合我国现行法律和基本伦理原则,深入分析了免除伦理审查的前置条件和适用情形在适法性与可操作性上可能存在的问题,并在此基础上提出了可行性的建议：第一,明确监管范围,免除伦理审查是一种特殊的审查方式,而非不进行伦理审查;第二,全面评估风险,对研究的风险判断不仅要考虑因研究给个人带来的生理风险,还应考虑其心理、经济、社会以及法律等方面的风险,尤其是对最小风险应明确界定;第三,界定前置条件中的具体概念,以及在此基础上适用情形的判断,制定具体、合理、合法的实施细则,为免除伦理审查的实施提供参考。

     

Predicting Compliance with Sanitary Behaviors among Students in Higher Education During the Second COVID-19 Wave: The Role of Health Anxiety and Risk Perception

To limit the spread of COVID-19, public authorities have recommended sanitary behaviors such as handwashing, mask-wearing, physical distancing, and social distancing. We recruited a large sample of higher education students in Belgium (N = 3201–3441) to investigate the role of sociodemographic variables, mental health, previous COVID-19 infections, academic involvement, and risk perception on adherence to these sanitary behaviors. This cross-sectional study took place during the second COVID-19 wave in Belgium, between February and March 2021. Analyses showed that living alone, being female, later in the academic curriculum, having higher general and health anxiety, higher academic involvement, and higher risk perception were positively associated with adherence to the four aforementioned sanitary behaviors. Conversely, previous infection with COVID-19 and having been quarantined were negative predictors. Our results show a set of predictors highly similar for the four sanitary behaviors. We discuss potential initiatives to increase adherence to sanitary behaviors in this group of highly educated youngsters.     

患者决策能力与风险相关标准

患者决策能力对于患者享有临床知情同意权具有重要意义。风险相关标准主张决策所需的能力水平应该根据决策的结果来调整,单一的决策能力标准是不够的。决策结果带来的风险越大,能力水平要求越高,反之则可以要求较低的能力水平。该主张的伦理本质是不合理家长主义,并且,它意味着对同一决策任务,个体可能只有同意的能力而没有拒绝的能力,因而在经验上也站不住脚。患者决策能力标准仅应根据决策本身的复杂性和难易程度视该决策特性来决定,而独立于患者实际决策结果。     

免除伦理审查制度及其应用实践建议

2023年发布的《涉及人的生命科学和医学研究伦理审查办法》（以下简称《办法》）首次设立了免除伦理审查制度。该制度设计旨在提升伦理审查效率,但也面临一系列的应用实践挑战。从澄清免除伦理审查的概念入手,简要分析免除伦理审查制度设计的初衷和必要性,同时,以美国为例,介绍了免除伦理审查制度的国际进展以及既往实践的经验教训。最后,针对《办法》提出的免除伦理审查相关要求的重点和难点进行了探讨,并就免除伦理审查的决定主体、标准操作程序,以及免除伦理审查的研究的跟踪审查等应用实践细节提出初步建议。

     

Longitudinal interplay of young children's negative affectivity and maternal interaction quality in the context of unequal psychosocial resources

Interaction quality and child temperament predict early and later child development. Research hints at transactional interrelations of both aspects but lacks adequate data to examine this assumption. Maternal psychosocial resources are suspected moderators in this context but rarely taken into account. Drawing on data of the German National Educational Panel Study we conducted a cross-lagged panel analysis on the longitudinal interplay of maternal interaction quality and children's negative affectivity at 6–8, 16–18, and 25–27 months and compared mothers with and without accumulated strains. Both variables showed moderate to high structural and rank order stability over time and low but increasing connections. In the case of accumulated stress factors, interaction quality is clearly impaired and high negative affectivity acts as an additional burden while low negative affectivity helps strained mothers to maintain higher interaction quality but only in the first year of life.     

Risky behavior in young adult pedestrians: Personality determinants,correlates with risk perception,and gender differences

Based on the risk homeostasis theory, the aim of this study was to assess acceptable risk, measured by personality factors, and risk perception, measured by physiological arousal, as predictors of risky behavior in young adult pedestrians, as well as to assess for gender differences. Eighty-two young adults, aged 18–30, completed self-report measures about risky pedestrian behaviors and these personality traits: impulsiveness, conscientiousness and openness to experience. Sixty-four of these participants then took part in an experimental task designed to assess their perception of the level of risk in situations involving different interactions between cars and pedestrians. Risk perception was assessed by these physiological responses: heart rate, skin conductance level, and skin conductance response. Results showed that risky behavior had significant correlations with impulsiveness, conscientiousness, and skin conductance level. Gender differences also emerged in risky behavior, impulsiveness, conscientiousness, and skin conductance level. Finally, a structural equation model showed that impulsiveness, conscientiousness and the difference in skin conductance level between risky and neutral situations predicted risky pedestrian behaviors, and explained 23.6% of the its variance, after controlling the effect of gender. Implications for evaluation, prevention, and intervention for risky pedestrian behaviors are discussed.     

Who drops-out? Do measures of risk to self and to others predict unplanned endings in primary care counselling?

Aims: Unplanned endings, where clients unilaterally end therapy, are of concern for psychological therapy services generally as they raise questions about the appropriateness of the treatment and it's delivery for some clients. Limited available data indicates that those who drop-out often have more severe symptoms at entry, and have poorer clinical outcomes. This raises further questions about risk to self and others for those clients who leave therapy prematurely and how these clients might be identified and kept engaged. Method: This paper uses a large dataset of CORE data collected routinely in a primary care counselling service between 2000 and 2003. Logistic regression was utilised to consider different measures of risk and other client characteristics recorded at assessment to predict drop-out from the service. Results: These indicate that younger age, greater psychological distress at assessment, an addiction problem and greater risk to others, are associated with an unplanned ending. However, no reliable logistic regression model could be produced. This may be partly due to data quality issues or important characteristics not being available in the data. Implications for practice: The paper concludes that counsellors should actively seek to minimise unplanned endings, as amongst them may be represented the more distressed and risky clients referred to primary care counselling.     

Spread of Risk Information Through Microblogs: Twitter Users with More Mutual Connections Relay News That is More Dreadful1

In elucidating the spread of risk information through microblogging, it is important to understand the behaviors of numerous average users, in addition to the activities of authorities. We followed the transmission pathways of 10 actual widely spread tweets concerning several risk information topics, including natural disasters, nuclear disasters, and infectious diseases, and we identified the types of risk that affected retweeting by classifying each tweet based on Slovic's risk-perception model. Furthermore, we examined the types of users who did and did not retweet the information. Users with few connections in the form of followers (i.e., people who are following a user) or followees (people a user is following), or with a low ratio of mutual followers within their connections, had a tendency to retweet a large amount of risk information, regardless of the type of risk involved. On the other hand, users with a high ratio of mutual followers exhibited a greater tendency to retweet risk information when it was perceived as dreadful, though they did not retweet risk information much on the whole. These results suggest that there are two mechanisms by which risk information is spread within the Twitter network: information exchange and social sharing of personal reactions.     

Support for distracted driving laws: An analysis of adolescent drivers from the Traffic Safety Culture Index from 2011 to 2017

IntroductionAdolescent drivers are often the focus of traffic safety legislation as they are at increased risk for crash-related injury and death. However, the degree to which adolescents support distracted driving laws and factors contributing to their support are relatively unknown. Using a large, nationally weighted sample of adolescent drivers in the United States, we assessed if perceived threat from other road users’ engagement in distracted driving, personal engagement in distracted driving behaviors, and the presence of state distracted driving laws was associated with support for distracted driving laws.MethodsThe sample included 3565 adolescents (aged 16–18) who participated in the Traffic Safety Culture Index survey from 2011 to 2017. A modified Poisson regression model with robust errors was fit to the weighted data to examine support for distracted driving laws. Models included age, gender, year, state distracted driving laws, personal engagement in distracted driving behavior, and perceived threat from other road users’ engaging in distracted driving.ResultsApproximately 87% of adolescents supported a law against texting and emailing compared to 66% who supported a universal handheld cellphone law. Support for distracted driving legislation was associated with greater perceived threat of other road users engaging in distracted driving while accounting for personal engagement in distracted driving, state distracted driving laws, and developmental covariates.DiscussionGreater understanding of the factors behind legislative support is needed. Public health interventions focused on effectively translating the risks of cellphone use while driving and effective policy will further improve the traffic safety culture.     

Evaluating the effectiveness of Didi ride-hailing security measures: An integration model

Security is one of the most critical factors influencing individuals’ mobility. Ensuring security along ride-hailing trips is also a fundamental challenge to service providers. After two cases of rape and homicide, Didi has rectified measures again to meet passengers’ need for security. However, there are few scientific findings concerning the impact of Didi rectified measures on personal perception of security. This study aims to explore critical latent factors that affect individuals’ intentions to use or reuse ride-hailing after the rectification of security measures. This paper examines individuals’ usage intentions by integrating and expanding both the Technology Acceptance Model (TAM) and the Theory of Planned Behavior (TPB). Research results suggest that perceived security, security risk, and government credibility are correlated with the intentions to use or reuse ride-hailing. Importantly, perceived security and security risk both have a direct impact on behavioral intentions from a different perspective. In contrast, government credibility has an indirect effect. Hence, a mediating effect test is conducted. Government credibility could indirectly influence behavioral intention by affecting trust. Finally, this study verifies that the effectiveness of security measures could be evaluated and improved by studying the influence of latent factors on the intentions to use or reuse ride-hailing.